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Date: 2022-07-11 Category: Not Applicable State: Union Government Country: India

NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF JUNE-2022

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

Key Changes

  • The spurious findings were reported by the Central Drugs Standard Control Organization (CDSCO) and confirmed by testing at the Central Drugs Laboratory, Kasauli.
  • Two batches of Covishield vaccine have been declared as 'Spurious': Batch No. 4121MC040 (manufactured 07.07.2021, expiry 06.04.2022) and Batch No. 4121MC019 (manufactured 14.06.2021, expiry 13.03.2022).

What it means

  • The gazette notification is a 'Not of Standard Quality Alert' issued for June 2022, specifically highlighting Covishield vaccine batches found to be spurious by the Central Drugs Laboratory (CDL), Kasauli.

Impact Analysis

Impact on Public Health

  • Need for investigation into how these spurious vaccines entered the supply chain.

Impact on Manufacturer

  • Increased scrutiny of manufacturing processes and quality control measures.

Impact on Government

  • Potential for public outcry and political pressure due to concerns about vaccine quality and safety.

Suggested Action Items

  • Review and update existing drug regulations to ensure they are adequate to deter and punish the production and distribution of spurious drugs.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. Central Drugs Laboratory, Kasauli: A central drug testing laboratory in India responsible for testing and analyzing drugs and vaccines. Covishield Vaccine: A COVID-19 vaccine developed by AstraZeneca and Oxford University, and manufactured by the Serum Institute of India.
Official Source Record View Original Source →
See Full Document Text
NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF JUNE-2022. A. Central Laboratories Manufacturing Expiry Reported by CDSCO S.No. Vaccine Name Batch No. Manufactured By NSQ Result Date Date Laboratory 1 Covishield Vaccine 4121MC040 07.07.2021 06.04.2022 Spurious Spurious Central Drugs Laboratory, Kasauli 2 Covishield Vaccine 4121MC019 14.06.2021 13.03.2022 Spurious Spurious Central Drugs Laboratory, Kasauli

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